Penza

Researchers are evaluating the effects of long-term lipid-lowering therapy on heart electrical activity, heart muscle movement, blood vessel stiffness, and quality of life in patients who have experienced their first ST-elevation or non-ST-elevation myocardial infarction (heart attack). This phase 4 clinical study will include 300 patients hospitalized at Penza regional clinical hospital in Russia. The goal is to understand how these treatments affect heart function and patient well-being over time. Patients will begin treatment with atorvastatin at a dose of 80 mg daily, started within 24 to 96 hours after the heart attack, alongside standard therapies such as dual antiplatelet therapy, ACE inhibitors, and beta-blockers if needed. If LDL cholesterol levels remain above 1.5 mmol/L after 5 to 6 weeks, ezetimibe 10 mg once daily will be added. Other supportive medications like proton pump inhibitors and nitrates may also be prescribed as indicated. The total follow-up period for participants is 96 weeks. Throughout the study, participants will undergo blood tests, advanced heart ultrasound imaging, long-term ECG monitoring, and ultrasound assessments of blood vessels. Researchers will also measure heart rhythm stability, heart muscle strain, vascular stiffness, exercise capacity, and quality of life through questionnaires. Treatment adherence will be tracked by counting remaining tablets and using specific questionnaires. The study will monitor heart electrical instability and heart rate turbulence over up to 120 hours and ventricular arrhythmias and heart function for up to 48 months.

Researchers are studying the effects of early inclisiran treatment in patients who have experienced a heart attack, specifically STEMI or non-STEMI, in real-world settings in Russia. The study focuses on patients with myocardial infarction and dyslipidemia, aiming to evaluate the clinical outcomes over 12 months after starting inclisiran in addition to basic therapy. Key goals include understanding how this treatment affects lipid profiles, the safety of the therapy, the condition of atherosclerotic plaques using carotid ultrasound, hospitalization rates, and the need for intensive follow-up care. Participants will receive their first inclisiran injection within approximately two weeks after their heart attack. The study observes the effects of this early treatment across a 12-month period, monitoring how inclisiran influences cholesterol levels and cardiovascular health alongside usual care. The research is designed to capture real-world data on inclisiran's impact on patients recovering from myocardial infarction. During the study, participants will be monitored for heart-related events, changes in cholesterol levels, and the status of arterial plaques. Researchers will also track hospital admissions and assess the safety of the treatment. The main outcome measured is the number of patients who experience atherosclerotic cardiovascular disease events within 12 months after starting inclisiran. Overall, the study aims to provide a comprehensive understanding of inclisiran's effects on heart health over one year.

Researchers are evaluating the effectiveness and safety of a non-immunogenic recombinant staphylokinase compared to a placebo in patients with intermediate high-risk pulmonary embolism (PE) who have normal blood pressure. This study focuses on patients who have right ventricular dysfunction and an increased risk of early death or hemodynamic collapse but are hemodynamically stable. The goal is to see if this treatment can improve outcomes without the risks seen in other thrombolytic therapies, such as hemorrhagic stroke. Participants receive either a single intravenous bolus of 15 mg of non-immunogenic recombinant staphylokinase or a placebo, both reconstituted in 15 ml of saline and given over 10-15 seconds. This single-dose treatment is compared to understand its safety and efficacy in reducing complications from intermediate high-risk PE. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial. Throughout the study, participants are monitored for outcomes including death, hemodynamic collapse, or recurrent PE within 30 days. Researchers assess heart function through imaging, blood tests such as troponin I levels, and clinical signs to evaluate treatment effects and safety. Patients must provide informed consent and agree to use reliable contraception during and shortly after the study. The total participation time includes initial diagnosis up to at least 30 days of follow-up to track key health events.

Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.

Researchers are evaluating the effectiveness and safety of Raphamin in treating adults aged 18 to 75 years with acute rhinosinusitis, a condition characterized by symptoms such as facial pain and nasal congestion. This multicenter, double-blind, placebo-controlled, randomized clinical trial enrolls patients within 48 hours of symptom onset during the seasonal peak of acute respiratory viral infections. The study uses the Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) to assess symptom severity and quality of life. Participants are randomly assigned to receive either oral Raphamin or a placebo following the same dosing schedule for five days. The trial includes a screening and randomization period of up to one day, a five-day treatment phase, and a follow-up period lasting up to 14 days. Patients attend three in-person visits on days 1, 4, and 7, with an additional phone visit on day 14. During these visits, symptom assessments, physical examinations, and diary reviews are conducted to monitor treatment adherence and safety. Patients keep an electronic diary twice daily to record body temperature and symptom changes according to the MSS. Investigators evaluate symptom progression, adherence, safety, and any complications including the use of antibiotics or hospitalizations. The primary outcome is the percentage of patients showing improvement in acute rhinosinusitis symptoms by day 4. Symptomatic and concomitant disease therapies are allowed except for prohibited medications. Overall, participants are observed for up to 14 days to assess treatment impact and safety.

Researchers are evaluating the efficacy and safety of the drug Reamberin solution for infusion, 1.5%, for treating viral enteric infection in children aged 1 to 6 years. This study focuses on children of both sexes diagnosed with viral and other specified intestinal infections who show clinical signs of endogenous intoxication and require infusion therapy. The trial aims to understand how well Reamberin works and how safe it is when used as part of routine clinical care. Participants receive Reamberin at a daily dose of 10 mL per kg of body weight along with fluids such as normal saline, glucose solutions, or Ringer's solution. The treatment is given by infusion under the supervision of a physician. The study is observational, involving monitoring children who have been prescribed Reamberin and supportive fluids as part of their treatment. During the study, researchers assess how many children continue infusion therapy at 24 and 48 hours after starting treatment, the average duration of infusion therapy, and symptom duration related to gastrointestinal damage and intoxication. They also evaluate the severity of illness 48 hours after treatment begins and how long children stay in the hospital. Parents or legal representatives provide informed consent, and the total participation includes treatment and monitoring of outcomes in a clinical setting.